MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-02 for SIZEWISE * manufactured by Sunflower Medical Llc.
[21766289]
Lift team staff were lowering head part of the shuttle sizewise bariatric chair, when the head part jerked down quickly. Patient immediately c/o (complained of) back pain. Patient stated that "it felt like a whip lash. " central supply notified. Sizewise representative assessed the chair. Ordered spine xray. No patient harm: negative xray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4894666 |
| MDR Report Key | 4894666 |
| Date Received | 2015-07-02 |
| Date of Report | 2015-07-02 |
| Date of Event | 2015-06-15 |
| Report Date | 2015-07-02 |
| Date Reported to FDA | 2015-07-02 |
| Date Reported to Mfgr | 2015-07-07 |
| Date Added to Maude | 2015-07-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIZEWISE |
| Generic Name | DEVICE, TRANSFER, PATIENT, MANUAL |
| Product Code | FMR |
| Date Received | 2015-07-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNFLOWER MEDICAL LLC |
| Manufacturer Address | 206 JEFFERSON ST. ELLIS, KS 67637 US 67637 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-02 |